MixNMatch COVID Booster Study - A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA Vaccines (NIH / DMID)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Sars-cov-2 Infection.Infectious Diseases
-
Age: Between 18 - 99 Years
-
Gender: Male or Female
-
Other Inclusion Criteria:
- You completed your original COVID-19 vaccine at least 12 weeks ago
- You are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures
- You are determined to be in good health by medical history, targeted physician examination and clinical judgement of the investigator
- Female participants of childbearing potential may be enrolled in the study, if all of the following apply:
- You practiced adequate contraception for 28 days prior to the first dose of vaccine (Day 1)
- You agree to continue adequate contraception through 3 months following the booster dose
- You have a negative pregnancy test at screening and on the day of the first vaccine dose (Day 1)
- You are not currently breastfeeding
You may not be eligible for this study if the following are true:
-
- You previously had a COVID-19 infection
- You previously received any research coronavirus vaccines (SARS-CoV, MERS-CoV) or any COVID-19 monoclonal antibodies in the last 90 days or are currently taking part in or plan to take part in another research study
- You have a history of anaphylaxis, hives, or other serious allergic reactions that required medical attention after receiving a vaccine or any nanolipid particles
- You received any research study product 28 days before study enrollment
- You received or plan to receive any other non-study vaccine 28 days before or after any dose of the study vaccine
- You have any bleeding conditions diagnosed by a doctor or experience any significant bruising or bleeding with intramuscular injections or blood draws
- You have an immunocompromised or immunosuppressive condition or any immune-mediated disease
- In the last 6 months, you received any systematic immunosuppressants or medications that affect your immune system for more than 14 days before your screening visit
- You received any immunoglobulin or blood-derived products within 90 days before the first study vaccine
- You are acutely ill or have a fever 72 hours before or at the time of the study vaccine dosing visit
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.